Details for New Drug Application (NDA): 203244
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The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 203244
Tradename: | GABAPENTIN |
Applicant: | Strides Pharma |
Ingredient: | gabapentin |
Patents: | 0 |
Pharmacology for NDA: 203244
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 203244
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | TABLET;ORAL | 203244 | ANDA | Quality Care Products, LLC | 55700-780 | 55700-780-30 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-780-30) |
GABAPENTIN | gabapentin | TABLET;ORAL | 203244 | ANDA | Quality Care Products, LLC | 55700-780 | 55700-780-60 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-780-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Jul 12, 2013 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jul 12, 2013 | TE: | AB1 | RLD: | No |
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